SOP Corrective and Preventative Action
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Use this SOP Corrective and Preventive Action (CAPA) template to systematically document, implement, and track actions taken to address and prevent actual or potential quality issues and nonconformities in your medical device processes, products, or services. This template is essential for meeting key ISO 13485, FDA 21 CFR 820.100, and MDR/IVDR requirements, and should be filled out whenever nonconformities, audit findings, customer complaints, or other significant quality events arise that require root cause analysis and long-term resolution. Completing this SOP ensures regulatory compliance, supports continuous improvement, and helps maintain the safety and effectiveness of your medical devices.